Vancomycin for C Difficile NAAT+/EIA- Hematology Oncology Patients

Medical College of Wisconsin

Status and phase

Completed

Phase 2

Conditions

Bone Marrow Transplant

Clostridium Difficile Infection

Oncologic Disorders

Hematologic Diseases

Treatments

Drug: Vancomycin Oral Capsule

Drug: Placebo Oral Capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT03030248

PRO00028749

Details and patient eligibility

About

This study will randomized hematology oncology patients with active diarrhea and a NAAT positive/toxin EIA negative to either 14 days of oral vancomycin capsules or placebo. The study is designed to include 30 patients (15 per arm).

Outcomes will include C. difficile load using qPCR, VRE loads, structural and functional microbiome changes and frequency of bowel movements. All endpoints will be measured at several time points including days 0, 14, 21 and 90.

Full description

The adverse health consequences resulting from antibiotic overtreatment of NAAT(+), toxin(-) patients may be particularly important in transplant recipients. The usual treatment prescribed for CDI at the Froedtert Memorial Lutheran Hospital is oral vancomycin. While this drug has excellent activity against C. difficile and commonly suppresses its growth to non-detection, it does not eradicate carriage and its use results in marked and prolonged disruption of the lower intestinal microbiota. Meanwhile, the degree of lower intestinal microbiota disruption at the time of HSCT engraftment has been demonstrated to be an independent predictor (controlling for other markers of underlying disease) of overall and transplant-related 3-year mortality.14 In addition, recent findings suggest that bone marrow suppressive effects of antibiotics, in this case potentially unnecessary oral vancomycin (which is not appreciably absorbed), may be solely mediated via microbiota disruption. All these data supports the notion that antibiotic treatment of NAAT(+), toxin(-) C. difficile patients might have significant negative repercussions without a clear clinical benefit.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients admitted to the hematology oncology inpatient units at Froedtert Memorial Lutheran Hospital
New onset of diarrhea during hospitalization
C. difficile clinical testing showing NAAT positive EIA negative results

Exclusion criteria

Being unable to consent for self
Inability to take enteral medications
Unwillingness to enroll in study
Patient has a documented allergy to vancomycin
Patient has a documented life expectancy shorter than treatment course (14 days)
Patient is unwilling or unable to provide stool samples in the outpatient setting after discharge
Diagnosis of C. difficile colitis [NAAT (+) and toxin EIA (+) within 3 months of enrollment).
New onset of abdominal distention within 24 hours prior to the onset of diarrhea during index admission
Presence of toxic megacolon
Presence of clinical sepsis. Sepsis will be defined as a Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score of 2 points or more as per 2016 definitions
Pregnancy or lactating